What is an In Vivo CRO?
An in vivo contract research organization (CRO) specializes in conducting preclinical drug testing and research using live animal and human subjects. This type of testing is an essential part of the drug development process, providing data on a candidate drug's safety, toxicity and efficacy before human clinical trials can begin.
In vivo CROs Offer Core Services
Pharmacology Studies
One of the core services provided by In Vivo CRO is pharmacology studies. These studies assess how a drug behaves within a living system, including how it is absorbed, distributed, metabolized and excreted (ADME). Pharmacology studies in animal models aim to understand therapeutic dose ranges, optimal dosing schedules, drug-drug interactions and more before moving to first-in-human trials.
Toxicology Testing
Another vital service is toxicology testing to evaluate drug safety. In vivo CROs conduct acute, subacute and chronic toxicology studies, as well as genetic toxicology assays. These studies uncover potential adverse effects like organ toxicity at different dose levels over time periods relevant to the planned clinical trial duration. Toxicology data guides decisions on safe starting doses for initial human studies.
Formulation and Drug Delivery Research
In vivo CROs also assist with research into drug formulation and delivery methods. This includes evaluating different administration routes, development of drug delivery systems like implants or injectables, and optimizing formulation properties like solubility, stability and bioavailability. Understanding how a drug formulation performs within a living system is crucial before moving to clinical use in humans.
Disease Models and Proof-of-Concept Studies
In vivo CROs can establish animal disease models to test new drugs' efficacy, conducting initial proof-of-concept studies. Models seek to recapitulate human diseases as closely as possible to provide meaningful data on therapeutic benefits in conditions like cancer, diabetes, arthritis and more. These studies evaluate if a drug demonstrates the intended pharmacology in a translatable model of the clinical indication.
Specialized In Vivo Testing Services
Beyond core service areas, many leading in vivo CROs offer highly specialized testing options tailored to their clients' unique R&D needs and projects. This can include advanced imaging techniques, sophisticated surgical models, and specialized toxicology assays measuring endpoints like immunogenicity, biomarkers or organ-specific parameters. In vivo CROs support diverse research areas from small molecules to cell and gene therapies.
In Vivo CROs Foster Translational Research
Coordinating Preclinical Programs
As full-service providers, in vivo CROs handle entire preclinical programs from study design through reporting. Their project managers coordinate all aspects from model selection and protocol development to researcher training, experimental procedures, data analysis and report preparation according to global regulatory standards like GLP. This streamlines preclinical testing and fosters fast, smooth translation to human trials.
Facilitating Cross-Group Collaboration
In vivo CROs facilitate valuable collaboration between their own experienced researchers and scientists at biotech and pharmaceutical sponsors. Together, cross-functional teams work to optimize study design considering the drug's profile, development goals and regulatory requirements. This collaborative approach improves protocol quality and data interpretation to best inform critical Go/No-Go decisions.
Utilizing Advanced Research Facilities
Leading in vivo CROs maintain state-of-the-art, AAALAC-accredited facilities housing specialized models and research technologies. Their laboratories boast expert technical staff, optimized animal housing and latest equipment for procedures like surgery and advanced imaging. Access to these top-tier resources significantly enhances preclinical research quality and efficiency.
Validating Animal-to-Human Translation
In vivo CROs validate animal models' predictive value for human response through retrospective analyses comparing preclinical and clinical safety/efficacy findings as clinical data emerges. Such translational research improves model selection and helps refine study designs for better human predicting going forward, further streamlining and de-risking drug development.
Get This Report in English Language: In Vivo CRO
Get This Report in Japanese Language: ใคใณใใCRO
Get This Report in Korean Language: ์์ฒด ๋ด CRO
About Author:
Ravina Pandya, Content Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. (https://www.linkedin.com/in/ravina-pandya-1a3984191)
